Z-0428-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 28, 2012
- Initiation Date
- October 19, 2012
- Termination Date
- December 11, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23
Product Description
IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Neuro III-SV Magnetic Resonance Imaging Systems.
Reason for Recall
IMRIS Inc. initiated a recall of their OR Tables ORT100 and ORT200. When proper procedure is not followed, the foot end of the IMRIS intra-operative OR table may be attracted to the MRI magnet as the magnet approaches the table. This poses a potential risk of injury to both the patient and operators standing near the table.
Distribution Pattern
Nationwide Distribution, including the states of FL, GA, IN, MD,MA, MI, MN, MO, TN, UT, and VA.
Code Information
10002845, 10002341, 10003244, 10002794, 10003243, 10003629, 10003801, 10002654, 10002796, 10002795, 10002846, 10002847, 10003830, 10003064, 10005201,10003754, 10004513